INDIANAPOLIS and TOKYO, May 26, 2020 /PRNewswire/ -- Sexton Biotechnologies and Ikeda Scientific today announced the completion of the certification process for eligibility of nLiven PR with PMDA as raw materials for manufacturing regenerative medicine products. Sexton's proprietary, pathogen reduced human platelet lysates, are manufactured with out-dated apheresis platelet units collected and processed in the United States.
The inclusion of pathogen reduction technology in Sexton's pooled human platelet lysate product offerings was initiated as a response to developing global regulatory expectations. In addition to using platelet units that meet U.S. FDA expectations for therapeutic use, the validated E-beam process provides viral inactivation while maintaining growth promoting properties.
"The review and confirmation of our PR treated products with PMDA is an accomplishment we are very proud of," said Sean Werner, President at Sexton. "The ability to provide this critical material to customers in Japan extends the impact our products can have on cell and gene therapy development."
Ikeda Rika Scientific began working with PMDA in late 2019 to register the product. "We are very pleased that the eligibility of nLiven PR has been confirmed by the PMDA," said Hideo Takahashi, President at Ikeda Scientific. "This process has been a challenge for Ikeda Scientific. However, we were confident in the eligibility and quality of this hPL product. By supplying Sexton's product, we will contribute to the development of regenerative medicine and life sciences in Japan."
With the recently introduced T-Cell validated T-Liven PR, Sexton's platelet lysates now include a range of human platelet lysates for immune-cell and MSC-based cell therapies.
ABOUT SEXTON BIOTECHNOLOGIES
Sexton Biotechnologies is a revenue stage, biotechnology company focused on the development and sales of bioproduction tools for cell and gene therapy founded in 2019 as a spin out of Cook Regentec, a life science incubator/accelerator located in Indianapolis, IN. Sexton develops purpose-built CGT tools and media to enable flexible automation and scaling of cell manufacturing processes to increase the probability of positive clinical outcomes and reduce time-to-market, failure points, and labor costs. Sexton's portfolio includes the CellSeal platform of cryo-storage tools and fill/finish systems and human platelet lysate growth supplements. More information at www.sextonbiotechnologies.com.